The transition time for the two Medical Device Regulations is rapidly ticking away: economic operators shall be fully compliant with the MDR by May 2020, and with the IVDR by May 2022. Are you an economic operator – in other words are you a Manufacturer, Authorized Representative, Importer, Distributor, System/Procedure Pack Assembler or Sterilization Service Provider? Then you might be eagerly waiting for further guidance (in the broadest sense of the word) from Europe. Here’s what guidance you can expect – and why you should not wait for it.
In November 2017, the Competent Authorities for Medical Devices (CAMD) issued a roadmap for implementation of the MDR/IVDR. CAMD identified seven technical areas/work streams and one over-arching/cross-cutting area/work stream. For each technical area/
Expect guidance documents and/or Implementing Acts on the topics of equivalence, well-established technologies, clinical evidence and performance evaluation. Several templates will be developed, such as templates for Summary of Safety and Clinical Performance, Clinical Investigation Application Form, SAE/device deficiency reports and timelines, PMCF Plan, and PMCF Report (and their IVD equivalents). For IVDs, new Common Specifications will be developed to replace the current Common Technical Specifications. Guidance regarding companion diagnostics is also to be expected.
With the revised classification rules for MDs and IVDs, guidance will be developed around classification rules and scope. Common Specifications are to be expected regarding Annex XVI products (products without an intended medical purpose). Implementing acts will be developed on the topic of reprocessing single-use devices. Also, expect guidance on the appropriate level of interacting with relevant authorities regarding combination products and companion diagnostics.
These are specific for Notified Bodies and not for Economic Operators, however for Economic Operators it will be interesting to see the development of these guidance documents as they will give insight in, for example, the different routes for conformity assessment, the definition of ‘significant change’, or the differences between IVD Class B and C conformity assessment procedures.
In addition, terminology might change as nomenclature for Adverse Events and Patient Harm will be (re)defined.
According to the CAMD roadmap, expect clear and early instruction to stakeholders on how to interact with the system. Guidelines will be developed on the topics of UDI assignment, UDI carriers, UDI marking
CAMD is going to develop guidance or infographics for Economic Operators clarifying expectations around economic operator obligations, responsible person, liability, interaction with Eudamed and registration requirements.
Specifically for IVDs, you can expect guidance on how to assess Class D IVDs in the absence of Common Specifications.
As already covered in previous work streams, also expect template documentation for performance studies, as well as guidance for assessment of companion diagnostics, classification, the appropriate level of interaction on combination products with relevant authorities, the nomenclature for Adverse Events and Patient Harm, and vigilance reporting.
Expect further definition of the responsibilities for conformity assessment of parallel importers and reprocessing of single-use devices. Also, guidance will be developed on the clarification of the role of the Medical Device Coordination Group (MDCG) in the governance of the regulations. Action items are defined to ensure that Eudamed will go live as planned (March 2020). As covered in the Eudamed work stream, instructions will be released to stakeholders on how to interact with the system. Current status is that functional specifications for Eudamed are to be released in May 2018, which implies that the progress towards the go-live date is still on track.
In January of this year, transitional provisions have been released by the CAMD Transition Sub Group, in the form of FAQs for both the MDR and the IVDR, covering initial questions on the topics of Eudamed, placing on the market of MDR/IVDR-compliant devices until date of application, placing on the market of MDD/AIMDD/IVDD-compliant devices after date of application, and the “sell off” provision in the MDR/IVDR. Keep an eye on these FAQs, as they are intended to evolve and expand over time.
Are you an economic operator waiting for guidance from Europe? Then there is little doubt that the expected guidance documents will be instrumental to you in implementing the requirements of the MDR/IVDR. These guidance documents may come in various sizes and shapes:
|Delegated Act||Common Specification|
|Although not mentioned in the CAMD roadmap, Delegated Acts may be prepared and adopted by the European Commission. These non-legislative acts are based on, for example, specific objectives, content, scope, and duration that have been set out in the original legislative act (like the MDR or IVDR), and are considered to supplement or amend the original legislation. In other words, a Delegated Act tells us more about what actually is considered the law.||The use of harmonized standards is good practice in order to presume to be in conformity with the General Safety and Performance Requirements. But in case relevant harmonized standards are considered not sufficient, or perhaps even not existing, the Commission may adopt Common Specifications which will have the same use as the harmonized standards. Specifically, regarding IVDs, current Common Technical Specifications may be replaced by such Common Specifications.|
|MEDDEV-like guidance documents|
|Designed as non-legally binding guidelines, MEDDEVs
|Implementing Act||Other guidance documents|
|A non-legislative act that is considered to be procedural: a practical implementation of the rules that already exist in the original legislation, and thus may result in practical things such as templates, procedures, deadlines etcetera. In other words, an implementing act tells us how to implement the original legislation.||These include any kind of (non-legally binding) guidance not covered by the above, such as infographics or FAQs.|
But even though these guidance documents are highly-anticipated, here is why you should not wait for them – or more appropriately: why you should stop doing nothing while waiting for them.
It’s clear that the time that is left for you to get all the work done should not be underestimated. And the road ahead may be full of questions. You may find yourself at a crossroads now: should you sit and wait for guidance to arrive with the risk of having insufficient time left to become compliant, or should you get up and start transitioning already based on current knowledge with the risk of having to adjust once new guidance arrives?
Your best option is to start now and anticipate as best as you can on what is to come instead of wait and react. Start building a transition program based on what you can use from current guidance documents. As soon as new guidance documents are released, use these to double check to which extent you already comply with the MDR/IVDR, and to which extent you will have to fill any remaining gaps. This will get you further and will save you more time than doing nothing at all.
As we pointed out in our previous blog on MDR, time is running out fast: the longer you wait with the implementation of the MDR/IVDR requirements, the higher the risk will be that you will lose money.
Blog by: Urville Djasim – Consultant at Xendo